Course Agenda

Computer Validation General Overview

  • Computer Validation fundamentals a walk-through of a complete validation of a small example system
  • Who needs to validate?
  • What is Computer Validation?
    • Core principles
    • Brief history of computer validation
  • Why is validation necessary and what regulations guide validation requirements?
  • Review of the computer validation references in regulations and guidances:
    • 21 CFR Part 211
    • 21 CFR Part 810
    • 21 CFR Part 11
    • Annex 11: Computerized Systems
    • Guidance: Q7A GMPs for Active Pharmaceutical Ingredients
    • Guidance: General Principles of Software Validation
    • Guidance: Computerized Systems Used in Clinical Investigations
  • When and how are systems validated?
  • Review of key FDA Warning Letters related to computer validation

Computer Validation Process and Deliverables

  • What is the SDLC (System Development Life Cycle) process?
  • How does computer validation fit into the SDLC?
  • What content must be covered?
  • What are the expected tasks and deliverables?
  • System/software specifications
  • Requirements options and documentation
  • How 21 CFR Part 11 applies to computer validation
  • Design Qualification (DQ) and vendor selection
  • Risk Assessment in computer validation
    • Where does it apply?
    • A walkthrough of the GAMP risk assessment process
  • Validation Plans and Master Validation Plans
  • Installation Qualification (IQ)
    • The five topics expected in IQ documents
  • Operational Qualification (OQ) and Performance Qualification (PQ)
    • Testing strategies and level of detail
    • How much testing is enough?
    • Examples of effective test cases and system errors discovered
  • SOPs required for system operation and maintenance
    • How they related to FDA Warning Letters
  • Validation Summary Reportse


Overview of 21 CFR Part 11 (Part 11)

  • Background and purpose of Part 11
  • Overview of Part 11 (review regulation)
  • Review of the Part 11 implications in regulations and guidances:
    • 21 CFR Part 58 GLP
    • 21 CFR Part 211 GMP
    • 21 CFR Part 312 GCP (IND)
    • 21 CFR Part 810 QSR
    • Guidance: Part 11 scope and application (September 2003)
    • Guidance: Computerized Systems Used in Clinical Investigations
    • Guide to the Inspection of Pharmaceutical Laboratories
  • Review of Part 11-related FDA Warning Letters
  • Discussion of example systems and the evaluation of Part 11 Compliance decisions
  • Industry trends and approaches the future of Part 11 issues
  • Interactive discussion of Part 11 issues and concerns (bring your questions)
  • Achieving and Maintaining Part 11 Compliance

GAMP-Specific Computer Validation Topics

  • The industry guidance for Good Automated Manufacturing Practice (GAMP)
  • How GAMP addresses the FDA’s expectations for computer validation
  • GAMP 5 versus GAMP 4
  • How to transition to GAMP 5 from GAMP 4
  • A review of the supplementary GAMP guidances and where they apply

Auditing Computer Systems

  • Auditing GxP computer systems
  • Auditing suppliers of computer systems for GxP use
  • Auditing developers for customized systems
  • The general process for auditing computer systems
  • Variations that can save time and money
  • Review of an example audit checklist
  • Primary areas of focus (what to look for)
  • Examples of audit findings



Categories: Stem Cells therapy


contract research organization

stem cell therapy